SilverPlatter Guide

EINECS Plus (EINE)

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Introduction - what is EINECS Plus ?

EINECS Plus is a collection of important official chemical (inventory) information to assist with compliance to EC legislation on (dangerous) chemicals.  It is a unique combination of information from a number of related EC legislative sources:

(a)  The European inventory of existing commercial chemical substances, (EINECS), published in the Official Journal of the European Communities (OJ) C 146 A, 15.6.1990.

(b)  The European list of notified chemical substances (ELINCS), March 2005 edition.  This is based on data published currently on the European Chemicals Bureau's website (http://ecb.jrc.it/new-chemicals/) and includes all substances notified up to June 30th 2003.  Whereas the ECB version is available in English only, the EINECS Plus version presented here is available in English, French, German, Dutch, Italian, Spanish, Portuguese, Danish, Swedish and Finnish.

(c)  The EINECS Corrections (OJ C 54/13 01.03.2002, 2002/C54/08), which can be found within the EINECS Plus databases.

(d)  The No-Longer Polymers List: the definition of the term polymer was changed in 1992 and this led to some substances which were originally considered to be polymers to be no longer considered as polymers for the rules on the notification of new substances.  Such "no-longer polymers" do not retrospectively become subject to notification.  A non-exhaustive list of these substances has been drawn up and published by the Office for Official Publications of the European Communities, Luxembourg, 1997 ISBN 92-827-8995-0.  This data is available in English.

(e)  Annex I to Directive 67/548/EEC: the List of dangerous substances for which labelling is prescribed, contained in Annex I as last consolidated in Directive 93/72/EEC, OJ L 258, 16.10.1993 (19th adaptation to technical progress), and subsequently adapted by Directives 93/101/EEC, OJ L 13, 15.1.1994 (20th adaptation), 94/69/EC, OJ L 381, 31.12.1994 (21st adaptation), 96/54/EC, OJ L 248, 30.9.1996, (22nd adaptation), 97/69/EC, OJ L 343, 5.12.1997 (23rd adaptation), 98/73/EC, OJ L 305, 16.11.1998 (24th adaptation), 98/98/EC, OJ L 355, 30.12.1998 (25th adaptation), 2000/32/EC, OJ L 136, 8.6.2000 (26th adaptation), 2001/59/EC, OJ L 225, 21.8.2001 (28th adaptation) and 2004/73/EC, OJ L 152, 30.04.2004 (29th adaptation as subsequently corrected by OJ L 216, 16.06.2004 and L 236 07.07.2004).  The corrigenda to the 24th and 25th adaptations (OJ L 285 8.11.1999 and OJ L 293 15.11.1999 respectively) have also been incorporated into the list.  Please note that the 27th adaptation to technical progress (2000/33/EC, OJ L 136, 8.6.2000) did not make any changes at all to this list of dangerous substances.

Note that the phrase "ANNEX 1" (note the case) is used in many places in this guide to mean this source of data unless stated otherwise.

(f)  Annex II to Directive 67/548/EEC: Symbols and indications of danger for dangerous substances and preparations consolidated by Directive 93/21/EEC, OJ L 110, 4.5.1993 (18th adaptation), updated by the 28th adaptation (see (e) above) and revised again as a consequence of the accession of the 10 candidate countries to the EU (OJ L 236, 23.09.2003, p. 99 et seq.).

(g)  Annexes III and IV to Directive 67/548/EEC: also consolidated by the 18th adaptation, subsequently updated by the 23rd, 25th, 26th and 28th adaptations (see (e) above) and revised again as a consequence of the accession of the 10 candidate countries to the EU (OJ L 236, 23.09.2003, p. 99 et seq.), and entitled respectively 'Nature of special risks attributed to dangerous substances and preparations' and 'Safety advice concerning dangerous substances and preparations', these two Annexes contain the Risk and safety phrases to be used on labels.

(h)  A summary of EU legislation on dangerous substances and preparations: This is a collection of the key legislation affecting the classification, packaging and labelling of both dangerous substances and preparations.  It contains a consolidation of the substances directive and the new 1999 preparations directives as well as the full text of Directive 2001/58/EC on Safety Datasheets for dangerous substances and preparations.  Important aspects of the proposed REACH (Registration, Evaluation, Authorisation and Restrictions of Chemicals) legislation are included as well.

This legislation is a full-text database and is presented elsewhere in the EINECS Plus collection.

(i)  The European Cosmetics Inventory (ECI) (Commission Decision 96/335/EC of 8 May 1996 establishing an inventory and a common nomenclature of ingredients employed in cosmetic products) L 132, 1.6.1996.  There are 10 separate databases containing this data in English, French, German, Dutch, Italian, Spanish, Portuguese, Danish, Swedish and Finnish.

(j)  ECICS (European Customs Inventory of Chemical Substances), 2000 edition (incorporating the changes to the Combined Nomenclature of the EC as determined by Commission Regulation (EC) No 2204/1999 of (OJ L 278, 28.10.1999) amending Annex I to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff and is up to date as of June 2000.  ECICS is available in English, French, German, Dutch, Italian, Spanish, Portuguese, Danish, Swedish and Finnish in EINECS Plus.

(k).  "The EU Cosmetics Legislation" is another full text database included in the EINECS Plus compendium.

(l).  The European Waste Inventory (EWI) (Commission Decision 2000/532/EC of 3 May 2000 establishing a list of wastes) L 226, 6.9.2000 subsequently amended by Commission Decisions 2001/118/EC (L 47, 16.2.2001), 2001/119/EC (L 47, 16.2.2001), Council Decision 2001/573/EC (L 203, 28.7.2001) and corrected in OJ L 262, 2.10.2001 p. 38, OJ L 112, 27.04.2002 p. 47 and OJ L 272, 20.8.2004 p. 16.  There are 10 separate databases containing this data in English, French, German, Dutch, Italian, Spanish, Portuguese, Danish, Swedish and Finnish; the database-specific documentation for which appears elsewhere in this compendium.

(m).  Chemicals in the four EU Priority ListsEUPL (Commission Regulation (EC) No. 1179/94 of 25 May 1994, (L 131, 26.05.1994 p. 3-4);Commission Regulation (EC) No. 2268/95 of 27 September 1995, (L 231, 28.09.1995 p. 18-19), subsequently corrected by L 237, 06.10.1995, p. 8; Commission Regulation (EC) No. 143/97 of 27 January 1997 (L 25, 28.01.1997 p. 13-14) and Commission Regulation (EC) No 2364/2000 of 25 October 2000 (L 273, 26/10/2000 p. 5-7) respectively.

(n).  Lists of Binding and Indicative Occupational Exposure Limit Values in implementation of Council Directive 98/24/EC of 7 April 1998 (OJ L 131, 05.05.1998 p. 11) on the protection of the health and safety of workers from the risks related to chemical agents at work.

(o).  The list of chemicals subject to the Prior Informed Consent (PIC) procedure concerning the export and import of certain dangerous chemicals (Commission Regulation (EC) 304/2003 of 28 January 2003, L 63, 6.3.2003, p. 1 as subsequently amended by Commission Regulations 1213/2003 of 7.7.2003, L 169, 8.7.2003, p. 27 and 775/2004 of 26 April 2004, L 123, 27.4.2004 p. 27.

EINECS Plus 2005:1 contains a total of 32 databases in English, French, German, Dutch, Italian, Spanish, Portuguese, Danish, Swedish and Finnish.  The list below describes exactly what each database contains with reference to the lettered sections above:

EINECS Plus/ELINCS (03/2005) 2005:1:EN contains a,b,c,d,e,f,g,j,m,n,o (ENGLISH DATA ONLY).
EINECS Plus/ELINCS (03/2005) 2005:1:FR contains a,b,c,e,f,g,j,m,n,o (FRENCH DATA ONLY).
EINECS Plus/ELINCS (03/2005)2005:1:DE contains a,b,c,e,f,g,j,m,n,o (GERMAN DATA ONLY).
EINECS Plus/ELINCS (03/2005)2005:1:ES contains a,b,c,e,f,g,j,m,n,o (SPANISH DATA ONLY).
EINECS Plus/ELINCS (03/2005) 2005:1:DA contains a,b,c,e,f,g,j,m,n,o (DANISH DATA ONLY).
EINECS Plus/ELINCS (03/2005) 2005:1:NL contains a,b,c,e,f,g,j,m,n,o (DUTCH DATA ONLY).
EINECS Plus/ELINCS (03/2005) 2005:1:IT contains a,b,c,e,f,g,j,m,n,o (ITALIAN DATA ONLY).
EINECS Plus/ELINCS (03/2005) 2005:1:PT contains a,b,c,e,f,g,j,m,n,o (PORTUGUESE DATA ONLY).
ELINCS (03/2005)/ECICS+ 2005:1:FI contains b,e,f,g and j (FINNISH DATA ONLY).
ELINCS (03/2005)/ECICS+ 2005:1:SV contains b,e,f,g and j (SWEDISH DATA ONLY).
ECI (ENGLISH) contains i (ENGLISH DATA ONLY).
ECI (FRANÇAIS) contains i (FRENCH DATA ONLY).
ECI (DEUTSCH) contains i (GERMAN DATA ONLY).
ECI (ESPAÑOL) contains i (SPANISH DATA ONLY).
ECI (DANSK) contains i (DANISH DATA ONLY).
ECI (NEDERLANDS) contains i (DUTCH DATA ONLY).
ECI (ITALIANO) contains i (ITALIAN DATA ONLY).
ECI (PORTUGUÊS) contains i (PORTUGUESE DATA ONLY).
ECI (SUOMI) contains i (FINNISH DATA ONLY).
ECI (SVENSKA) contains i (SWEDISH DATA ONLY).
EWI (ENGLISH) contains l (ENGLISH DATA ONLY).
EWI (FRANÇAIS) contains l (FRENCH DATA ONLY).
EWI (DEUTSCH) contains l (GERMAN DATA ONLY).
EWI (ESPAÑOL) contains l (SPANISH DATA ONLY).
EWI (DANSK) contains l (DANISH DATA ONLY).
EWI (NEDERLANDS) contains l (DUTCH DATA ONLY).
EWI (ITALIANO) contains l (ITALIAN DATA ONLY).
EWI (PORTUGUÊS) contains l (PORTUGUESE DATA ONLY).
EWI (SUOMI) contains l (FINNISH DATA ONLY).
EWI (SVENSKA) contains l (SWEDISH DATA ONLY).
Summary of EU Legislation on Dangerous Substances and Preparations contains h (ENGLISH DATA ONLY).
The EU Cosmetics Legislation contains k (ENGLISH DATA ONLY).

WinSPIRS and WebSPIRS interfaces are currently available in English, French, German and Spanish.

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What's new in EINECS Plus 2005:1 ?

1).  The new version of ELINCS (March 2005) which includes 560 new entries is presented in English, German, French, Spanish, Italian, Danish, Dutch, Portuguese Swedish and Finnish.

2).  A new links field has been introduced (Links to Risk Assessment Documentation (RAR)) which is included for those substances in the EINECS inventory which are on one of the four Priority Lists.  Clicking on a link will open a separate browser window and display the linked document described in the link text.

4).  Occupational Exposure Limit data taken from Directives 91/322/EC of 29 May 1991 (OJ L 177, 05.07.1991, p. 22) and 98/24/EC of 7 April 1998 (OJ L 131, 05.05.1998, p. 11) have been added to EINECS Plus.  This change has added additional indicative exposure limits as well as the first binding exposure limit value.

5).  The German, Spanish and Italian versions of the European Waste Inventory (EWI) - included elsewhere in the EINECS Plus compendium - have been updated to reflect the corrigenda published in the Official Journal (OJ L 262, 2.10.2001 p. 38, OJ L 112, 27.04.2002 p. 47 and OJ L 272, 20.8.2004 p. 16).

6).  The Manual of Decisions for Implementation of the Sixth and Seventh Amendments to Directive 67/548/EEC on Dangerous Substances (Directives 79/831/EEC and 92/32/EEC) (Non-Confidential Version) on the full text database "Summary of EU Legislation on Dangerous Substances and Preparations" has been updated to reflect:-
 - a new foreword to ELINCS;
 - introduction of a new section entitled 'Alternative to the algae growth inhibition test with coloured substances';

This database has further been modified to include a description of the current status of the REACH proposals.  This document replaces the Impact Assessment presented in the previous edition of EINECS Plus.

7).  The European Cosmetics Legislation database has been updated to take account of Commission Directive 2005/9/EC of 28 January 2005 (OJ L 27, 29.1.2005, p. 46) amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annex VII thereto to technical progress.  It has further been updated to implement the Corrigendum to Commission Directive 2004/93/EC of 21 September 2004 amending Council Directive 76/768/EEC for the purpose of adapting its Annexes II and III to technical progress (OJ L 97, 15.4.2005, p. 63).

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About EINECS

EINECS is the European inventory of existing commercial chemical substances.  It was drawn up by the European Commission in accordance with the provisions of Commission Decision 81/437/EEC.  After publication in 1987 of an Advance Edition in English, EINECS was definitively published in nine Community languages in OJ C 146A, 15.6.1990.

EINECS lists and defines the 'existing' chemical substances which were present on the European Community market between 1 January 1971 and 18 September 1981.  In terms of art. 13 of Directive 67/548/EEC, OJ L 196, 16.8.1967 as amended to date (the Substances Directive), these substances are exempt from its pre-marketing notification provisions.

Notification has been obligatory for 'new' substances since the coming into force of Directive 79/831/EEC, OJ L 259, 15.10.1979 (6th amendment to the Substances Directive).  Once notified, such substances are listed in ELINCS, another principal component of EINECS Plus.  An obvious practical value of EINECS Plus is that it greatly facilitates the identification of substances in either list.

EINECS contains over 100100 entries.  Of this number, about 82000 are considered to be well-defined substances; the remainder, about 18000, are substances of Unknown or Variable composition, Complex reaction products and Biological materials (UVCB).  Approximately 5000 of these UVCBs have also a short description in addition to the name.

Substance records in EINECS include EC number (formerly called EINECS/ELINCS number), CAS number, IUPAC chemical name and Molecular formula fields.  A definition is provided in addition to the chemical name where the latter cannot be given precisely, such as for UVCB substances.

In EINECS Plus additional fields have been added to facilitate retrieval.  These are the Language of record and Database or List identifier fields.  A chemical name Synonym field also exists for many of the English-language EINECS records.

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About ELINCS

ELINCS is the European list of notified chemical substances.  It is compiled in accordance with the provisions of Commission Decision 85/71/EEC, OJ L 30, 2.2.1985, and it is planned to be issued in cumulative form approximately once a year.

EINECS Plus draws upon the March 2005 edition of ELINCS.  It is important to note that this information has been obtained from the web site of the European Chemicals Bureau (http://ecb.jrc.it/new-chemicals/) and has no legal status as it is NOT published in the Official Journal.  This edition covers all chemical substances notified within the EC up to 30th June 2003.  Furthermore, please note that whereas the Bureau has only published this edition in English only, this implemenation is presented in English, French, German, Dutch, Italian, Spanish, Portuguese, Danish, Swedish and Finnish.  Wherever possible, foreign IUPAC nomenclature has been carried forward from previous editions.  Otherwise, translations have been provided for new ELINCS chemical names.  Their unofficial and provisional nature are denoted by an asterisk (*) preceding the name.

This list replaces the previous list (the 7th, provisional, edition) and consists of all the chemical substances notified in accordance with Article 7 of the Directive.  This list supplements the European inventory of existing commercial chemical substances (EINECS) published on 15 June 1990, which lists all substances placed on the market up to 18 September 1981.  Apart from the exceptions provided for in Articles 1 and 13 of the Directive, all substances placed on the Community market or, in the case of a new substance, notified no later than 30th June 2003, including those which are components of preparations, appear in either EINECS or ELINCS.

Apart from the abovementioned exceptions, substances placed on the market which do not appear in either EINECS or ELINCS must have been notified or must be notified in accordance with the Directive, and will be included in an update of ELINCS.

The presence of a substance in ELINCS nevertheless does not dispense any new importer and/or new manufacturer placing it on the Community market from notifying it in accordance with the Directive.  However, if the substance has already been notified, the competent authority may accept that the new notifier refer, as far as the technical dossier is concerned, to the results of studies carried out by a previous notifier or notifiers, with his or their written agreement, in particular to avoid as far as possible the repetition of tests using vertebrate animals.

In accordance with Decision 85/71/EEC, the classification of these substances is included in ELINCS only if it has been officially adopted at Community level and therefore appears in Annex I to the Directive.  The other dangerous substances on the list, provisionally classified by the notifier, are in the process of being officially classified, and the official classification will be included in an update of ELINCS.

More information regarding notification and risk assessment of new substances is available here.

ELINCS records include an EC number, one or more Dossier number(s) and one or more Trade name(s).  IUPAC chemical names are also present in some records.

As with the EINECS records, additional fields have been added to facilitate retrieval.  These are the Language of record and Database or List identifier fields.

This edition of ELINCS contains 3827 records.

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Notification and Risk Assessment of New Substances

Most of what appears below has been extracted from the overview at the European Chemicals Bureau - ECB.

The New Substances work area at the ECB provides technical and scientific support to Member State Authorities and Commission Services mainly concerning the notification and risk assessment of new chemical substances to be placed on the European market.

Notification schemes for new chemical substances, manufactured or imported within EU industries, were first introduced during the nineteen-seventies by individual Member States.  Notification allowed a priori assessment of potential occupational/consumer risks and environmental impact.  A harmonised pan-European notification system was introduced for new substances as part of the 6th Amendment to Directive 67/548/EEC, concerned with the classification, packaging, and labelling of dangerous substances.  The 6th Amendment (Directive 79/831/EEC) was adopted in September 1979 and came into force in all Member States on 18th September 1981.  A 7th Amendment (Directive 92/32/EEC) was adopted in April 1992 with effect from November 1993 and introduced a risk assessment for new notified substances.  Over 6000 notifications in total, representing more than 3700 substances, have been submitted since 1981.

Inherent in the legislation are principles for notification, including criteria for exemption.  A fundamental definition makes distinction between new and existing chemicals which are delimited by the enforcement date of Directive 79/831/EEC.  Existing chemicals are listed in European INventory of Existing commercial Chemical Substances (EINECS) published in Official Journal of the European Communities on 15th June 1990.  That version of EINECS contained 100 106 entries, comprising substances introduced between 1st January 1971 and 18th September 1981.  New chemicals, introduced subsequently, form a cumulative index, European LIst of Notified Chemical Substances (ELINCS) periodically updated in the Official Journal or on the ECB website.  Exemption categories include consumer products pertaining to pharmaceutics, cosmetics and foodstuffs.  The Directive is not applicable to pesticides, radioactive materials, wastes, and substances used in scientific research.

Beside details on the notifier/manufacturer and the identity of the chemical (IUPAC name, CAS number etc.), a technical dossier for new substance notification should provide other pertinent information on the substance (e.g. production process, proposed uses) and results from analysis of physical and chemical properties, and test reports from toxicological and ecotoxicological assays.  Proposals for classification and labelling should be submitted, including recommended precautions relating to safety.  A risk assessment should be drafted.  Requisite dossier detail increases according to substance quantity, viz: 10kg, 100kg, 1000kg, per year per manufacturer (7th Amendment Annexes VIIC, VIIB, VIIA ("base-set"), respectively) with further toxicological and ecotoxicological testing required at amounts exceeding 100 and 1000 tonnes per year per manufacturer (Annex VIII).

Industry has to submit the notification dossier to the national Competent Authority.  Dossiers are evaluated by Competent Authority and forwarded to ECB Work Area New Substances in standard format using software incorporating Data Entry Screens (DES) and Structured Notification Interchange Format (SNIF).  The programs enable harmonised data assembly and exchange of summary information on new notified substances.  Aspects of dossier information are confidential, particularly chemical spectra and structures, which are not transmitted or archived in electronic form.  Dossier handling is managed through New Chemicals Database (NCD) maintained in a security area at ECB with authorised access only.  The Work Area maintains quality assurance of SNIF/NCD content and co-ordinates information distribution among EU Competent Authorities and Norway.

In general, there is the principle of mutual acceptance between the Competent Authorities of the Member States.  However, everybody participating in the system may comment in a written procedure. Issues related to implementation of Directives are discussed in meetings organised and chaired by the ECB (Technical and Scientific Meetings, Working Group Meetings) or DG Environment (Competent Authority Meetings).  The decisions taken at these meetings are collected in a "Manual of Decisions", which provides guidance for industry and other bodies involved in the notification of new substances.  The Manual of Decisions is published in the full text database entitled "Summary of EU Legislation on Dangerous Substances and Preparations" included elsewhere in the EINECS Plus compendium.

Further information about new chemicals including statistics, polymers and intermediates can be found at http://ecb.jrc.it/new-chemicals/.

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The List of dangerous substances

The List of dangerous substances, contained in Annex I to Directive 67/548/EEC (the Substances Directive) is a list of substances for which harmonized classification and labelling have been agreed at Community level in accordance with the procedure laid down in the Directive (Article 4(3)).  EINECS Plus draws upon the List of dangerous substances as last consolidated in Directive 93/72/EEC, OJ L 258, 16.10.1993 (19th adaptation to technical progress (ATP)), and subsequently adapted by Directives 93/101/EEC, OJ L 13, 15.1.1994 (20th adaptation), 94/69/EC, OJ L 381, 31.12.1994 (21st adaptation), 96/54/EC, OJ L 248, 30.9.1996 (22nd adaptation), 97/69/EC, OJ L 343, 5.12.1997 (23rd adaptation), 98/73/EC, OJ L 305 16.11.1998 (24th adaptation), 98/98/EC, OJ L 355 30.12.1998 (25th adaptation), the Corrigenda to the 24th and 25th ATPs (OJ L 285 8.11.1999 and OJ L 293 15.11.1999 respectively), 2000/32/EC, OJ L 136 8.6.2000 (26th adaptation), 2001/59/EC, OJ L 225 21.8.2001 (28th adaptation) and 2004/73/EC, OJ L 152, 30.4.2004 (29th adaptation as subsequently corrected by OJ L 216, 16.06.2004 and L 236 07.07.2004).  Please note that the 27th ATP (2000/33/EC, OJ L 136, 8.6.2000) did not make any changes at all to the list of dangerous substances.

For dangerous substances in the European inventory of existing commercial chemical substance (EINECS, OJ C 146A, 15.6.1990) the EINECS number is included.  This number is a seven-digit system of the type XXX-XXX-X which starts at 200-001-8.

For dangerous substances notified under the provisions of this Directive, the number of the substance in the European list of notified substances (ELINCS) is included.  This number is a seven-digit system of the type XXX-XXX-X which starts at 400-010-9.

For dangerous substances in the list of 'No-longer polymers' (document of the Office for Official Publications of the European Communities, 1997, ISBN 92-827-8995-0), the 'No-longer-polymer' number is included.  This number is a seven-digit system of the type XXX-XXX-X which starts at 500-001-0.

The Chemical Abstracts Service (CAS) number is also included where possible to assist identification of the entry.  It should be noted that the EINECS number includes both anhydrous and hydrated forms of a substance, and there are frequently different CAS numbers for anhydrous and hydrated forms.  The CAS number included is for the anhydrous form only, and therefore the CAS number shown does not always describe the entry as accurately as the EINECS number.

Substances in ANNEX I are principally identified by their Index number and their Labelling names.  Additionally, a Dangerous substance statement will always appear along with the Substance code and class field (derived from the Index number), Classification information, Risk phrases and Safety phrases.  Where the data are present in the ANNEX I record, the following fields will also appear: Graphic danger symbol(s), Indication(s) of danger, Concentration limits, Notes about the labelling of preparations and Notes about the identification/classification/labelling of substances.

As with EINECS and ELINCS records, additional fields have been added in the list of dangerous substances data to facilitate retrieval.  These are the Language of record and Database or List identifier fields.

Where, as in most cases, ANNEX I records can be linked via an EC number to EINECS, ELINCS or NLPL records, the link is made and the additional EINECS, ELINCS and NLPL fields will appear in these unified records.  If the link is not a one to one, direct, unambiguous one, a guidance note will appear in the Related record note field.  Please refer to the record linkage section for further information.

EINECS, ELINCS, "No-longer-polymer'' or CAS numbers are not usually included for entries which comprise more than four individual substances.

Groups of substances

A number of group entries are included in ANNEX I. In these cases, the classification and labelling requirements will apply to all substances covered by the description if they are placed on the market, insofar as they are listed in EINECS or ELINCS.  Where a substance that is covered by a group entry occurs as an impurity in another substance, the classification and labelling requirements described in the group entry shall be taken into account in the labelling of the substance.

In some cases, there are classification and labelling requirements for specific substances that would be covered by the group entry.  In such cases a specific ANNEX I entry will be present for the substance and the group entry will be annotated with the phrase 'except those specified elsewhere in this Annex'.

In some cases, individual substances may be covered by more than one group entry.  Lead oxalate (EINECS No 212-413-5) is for instance covered by the entry for lead compounds (index No 082-001-00-6) as well as for salts of oxalic acid (607-007-00-3).  In these cases, the labelling of the substance reflects the labelling for each of the two group entries.  In cases where different classifications for the same hazard are given, the classification leading to the more severe classification is used for the label of the particular substance (see Note A).

Entries in ANNEX I for salts (under any denomination) cover both anhydrous and hydrous forms unless specifically specified otherwise.

Substances with an ELINCS number

In ANNEX I, substances with an ELINCS number have been notified under the provisions of this Directive (2001/59/EC, L 225/1, 21.8.2001).  A producer or importer who has not previously notified these substances must refer to the provisions of this Directive if he intends to place these substances on the market.  This is a major difference between the notification procedures between the United States and the European Union.

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The evolution and updating of the list of dangerous substances

The List of dangerous substances was last consolidated in Directive 93/72/EEC, OJ L 258, 16.10.1993 (19th adaptation to technical progress (ATP)) and has since been adapted to technical progress nine times.  Cited in the paragraphs below are brief descriptions of the record number changes that have taken place in subsequent ATPs.

The 19th ATP introduced a total of 1388 records.

The 20th ATP (Directive 93/101/EEC, OJ L 13, 15.1.1994) added a further 100 records.

The 21st ATP (Directive 94/69/EC, OJ L 381, 31.12.1994) added a further 713 records and also included 127 revised records.

The 22nd ATP (Directive 96/54/EC, OJ L 248, 30.9.1996) added a further 52 records and also included 120 revised records.  The following 8 records were removed from the list (ANNEX 1 index numbers in square brackets):
 - liquid air [008-002-00-3]
 - 2-aminobenzidine [612-045-00-9]
 - Aromatic hydrocarbons, C8-10; Light Oil Redistillate, high boiling [648-011-00-5]
 - Tar, brown-coal; Carbolic oil [648-025-00-1]
 - Coke (coal tar), high temperature pitch [648-157-00-X]
 - Coke (coal tar), mixed coal-high temperature pitch [648-158-00-5]
 - Coke (coal tar), low temperature, high temperature pitch [648-159-00-0]
 - Natural gas, dried; Petroleum gas [649-192-00-3].

The 25th ATP (Directive 98/98/EC, OJ L 355 30.12.1998) added a further 167 records and also included 375 revised records.  The following 11 records were removed from the list (ANNEX 1 index numbers in square brackets):
 - bioallethrin; (+-)-3-allyl-2-methyl-4-oxocyclopent-2-enyl (+)-trans-chrysanthemate [006-075-00-6]
 - mixture of nitric and sulphuric acids containing ... % HNO3 [007-005-00-7]
 - diacetone alcohol, technical [603-017-00-7]
 - cyclobutane-1,3-dione [606-008-00-6]
 - naphthylindandione; 2-(1-naphthyl)indan-1,3-dione [606-015-00-4]
 - hexane-1,6-diyl bis(3-(3-benzotriazol-2-yl-5-tert-butyl-4-hydroxyphenyl)propionate) [607-193-00-6]
 - 3-methoxybutyl acetate [607-202-00-3]
 - tetranitronaphthalene [609-014-00-7]
 - diquat; 9,10-dihydro-8a,10a-diazoniaphenanthrene ion [613-005-00-3]
 - 3-allyl-2-methyl-4-oxocyclopent-2-en-1-yl-[1R-[1alpha(S),3]]-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropano- carboxylate; S-bioallethrin [613-055-00-6]
 - diphenylmethanediisocyanate, isomers and homologues [615-005-01-6]

The 26th ATP (Directive 2000/32/EC, OJ L 136 8.6.2000) added a further 104 records and also included 144 revised records.

The 28th ATP (Directive 2001/59/EC, OJ L 225 21.8.2001) added a further 349 records and also included 139 revised records.  The following 3 records were removed from the list (ANNEX 1 index numbers in brackets):
 - benzene, C10-13-alkyl derivatives [601-050-00-1]
 - salts of dinitrophenol [609-017-00-3]
 - paraquat (ISO); 1,1'-dimethyl-4,4'-bipyridinium [613-006-00-9]

The 29th ATP (2004/73/EC, OJ L 152, 30.4.2004 subsequently corrected by OJ L 216, 16.06.2004 and L 236 07.07.2004) added a further 446 records and also included 440 revised records.  The following 4 records were removed from the list (ANNEX 1 index numbers in brackets):
 - 4-chloro-o-cresol; 4-chloro-2-methylphenol [604-050-00-X]
 - salts of mecoprop [607-050-00-8]
 - daminozide; N-dimethylaminosuccinamic acid [607-171-00-6]
 - hexaconazole (ISO); (RS)-2-(2,4-dichlorophenyl)-1-(1H-1,2,4-triazol-1-yl)hexan-2-ol [613-130-00-3]

Errors in the Official Journal version of the 29th ATP have been identified and a Corrigendum is likely to be published in 2005 to rectify these errors.

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Class numbers of organic substances in the List of dangerous substances

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The EINECS Corrections

During the years in which the EINECS Inventory has been in use, a number of errors and omissions have been identified.  These may lead to a misinterpretation of entries as, for example, they may not correspond precisely to the substance which was reported.  It was agreed to establish a list of corrected entries after consultation with the Competent Authorities of the Member States for the implementation of Directive 67/548/EEC on the classification, packaging and labelling of dangerous substances.

The list has been published in the Official Journal (OJ C 54/13 01.03.2002, 2002/C54/08) and is incorporated in all the EINECS Plus databases (Greek, Finnish and Swedish excepted).

This list does not affect the rules used to describe substances in EINECS.  Only in those cases where an entry was insufficient or inaccurate has a correction been carried out.  Thus EINECS remains a closed list.

This database includes corrections which are valid for all language versions as well as corrections valid for the English-language version of EINECS.

The corrections contain all those entries where one or more of the descriptions (i.e. name and further definition, chemical formula, CAS registry number (CAS RN)) need to be revised.  The original EINECS number has always been kept.

Some examples of performed corrections are here reported:

1. Corrections of the chemical name

1.1. Typing error, e.g.:

2,4-Dichloro-6-methoxy-1,3,5-triazine (not . . . methoxy-3,5-triazine).

1.2. Change of the name (as it does not correspond to the submitted substance(s)), e.g.:

 - palmitic acid (not: palmitic acid, pure),
 - zinc abietate (not: zinc abietate, technical),
 - pentachlorobenzene (not: pentachlorophenol),
 - antimony oxalate (not: diantimony dioxalate oxide),
 - Extract residues (coal), creosote oil acid - A complex combination of hydrocarbons from the base-freed fraction from the distillation of . . . (not only: Extract residues (coal), creosote oil acid).

2. Correction of the chemical formula (which was wrong or missing), e.g.:

C26H36N12.2C2H3O2 (not: C24H30N12.2C3H6O2).

3. Correction of the CAS RN, e.g.:

CAS RN 5737-31-5 (not: CAS RN 1156-51-0).

4. Missed entries (i.e. an EINECS form was submitted for a substance which should have been included in EINECS but was not; a new Einecs number is allocated)

In some cases a group of reported substances needs to be described by more entries than were included in EINECS.  Others, despite having been reported, were not included at all.  In all these cases additional entries have had to be created with a new EINECS number. It should be noted that these entries correct only the incompleteness of EINECS.  They are NOT new entries.

E.g.

 - Distillates (coal tar), gasification, full range - The distillate from coal gasification tar having an . . . and three other entries (not only: Distillates (coal tar)),
 - Tar, coal, gasification - A complex combination of organic compounds obtained in . . . CAS RN 140203-30-1 (not covered precisely by: tar, coal, gasification, low temperature CAS RN 92062-19-6).

The EINECS Corrections data replace or augment the original EINECS data.  Additionally, the Revision Status field will contain the entry CORR if a record has been modified or added by this data.

Please note that the French and German versions include an extra set of 'missed' records not included in the other six languages.  The EINECS numbers of these extra records are 310-194-1, 310-199-9, 310-200-2, 310-203-9, 310-208-6, 310-209-1, 310-210-7 and 310-213-3.  The European Chemicals Bureau (http://ecb.jrc.it) has been informed of this anomaly and this issue will be resolved in a future EINECS Plus update.

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The No-Longer Polymers List

The following text is taken from the hardcopy text referring to the above entitled "Notification of New Chemical Substances in Accordance with Directive 67/548/EEC on the Classification, Packaging and Labelling of Dangerous Substances - No-Longer Polymers List", © ECSC-EC-EAEC,Brussels, 1997, ISBN 92-827-8995-0.

"No-Longer Polymers List
Explanations

1 ) GENERAL

Within the scheme of the notification of new substances (Directive 67/548/EEC) polymers are subject to special rules.  The term polymer was further defined in the 7th amendment (92/32/EEC) of the Directive.  This change means that some substances which were considered to be polymers under the reporting rules when the European Inventory of Existing Commercial Chemical Substances (EINECS) was being established are no longer considered to be polymers under the 7th amendment.

Polymers were not reportable for EINECS.  As all substances which are not present in the EINECS inventory are notifiable, all "no-longer polymers" should in theory be notified.

However, at the time when the 7th amendment was adopted, the Council of Ministers made it clear that these no-longer polymers should not, retrospectively, become subject to notification.  To facilitate the work of national Competent Authorities and the industry, the Commission was requested to draw up a list of no-longer polymers.

Substances to be included in this list have been on the EU market between September 18, 1981 , and October 31, 1993 and satisfy the requirement that they were considered to be polymers under the reporting rules for EINECS but are no longer considered to be polymers under the 7th amendment.  Therefore to create the no-longer polymer list industry was asked to submit their candidates.  The attached list is based on these submissions.

The list is not an exhaustive list.  The Competent Authorities are the responsible bodies, who shall decide whether a substance is a no-longer polymer or not but as a basis, they have decided that all the substances included in the attached list are to be regarded as no-longer polymers.  However, other substances may be regarded too as no-longer polymers if they satisfy the above conditions.  The decisions shall be taken by the Competent Authority concerned on a case by case basis.

Any substance on this list or which is decided by a Competent Authority to meet the criteria is exempt from notification.

2) DEFINITIONS

As polymers were not reportable and therefore not included in EINECS, in many cases it had to be decided whether a substance is a polymer or not by a desk examination of the submitted documents.

A widely used definition of polymers refers to the need for both a high molecular weight (more than 10000) and a molecular weight distribution.  In contrast, for decisions on the inclusion or otherwise in EINECS, the molecular weight of a substance was not taken into account.

Following the definition of the 7th Amendment a polymer is beside the molecular weight distribution also characterised "by the sequence of one or more types of monomer units and comprising a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant and consists of less than a simple weight majority of molecules of the same molecular weight" (Directive 92/32/EEC, Art. 2, 1c)).

The information available in the primary processing of substances reported for EINECS was not always sufficient to distinguish a polymer from a non polymer.  In particular only the name and the CA registry number was known for substances reported on the A or B forms used for reporting.  The first decision on whether a compound was a polymer or not had therefore to rely on the name and on the classification of the compounds in the Chemical Abstract Registry System.  Whenever a substance based on the information available was suspected of being a polymer, a problem letter was issued, and the submitter was asked to supply more detailed information on the size and distribution of the molecular weight.

Therefore decisions taken for the inclusion of submitted substances in EINECS did not follow general rules without any exception.  In some cases decisions were only based on the name of the submitted substance.

The no-longer polymer list contains only substances not included in EINECS.  For legal reasons, the definitions depend on the EINECS definitions and hence decisions on the notification status of e.g. a post-reacted NLP can be inferred by considering for this purpose an equivalence with EINECS rules.  Further requests on declaration of substances to be defined no-longer polymers have to be based on the rejection of a submission to EINECS.

NLP-Nos and name descriptions take precedence.  The CAS-RN given are to be treated as indicative and for a use as a searching tool.

3) THE NLP LIST CONSISTS MAINLY OF THE FOLLOWING GROUPS:

 - 3.1) alkoxylated substances
 - 3.2) oligomeric reaction products
 - 3.3) oligomers from one monomer only
 - 3.4) dimers and trimers
 - 3.5) polymer-like substances containing 50% or more by weight of species with the same molecular weight
 
 - 3.1) ALKOXYLATED SUBSTANCES

Alkoxylated substances which represent no-longer polymers are named ethoxylated, propoxylated and butoxylated substances and are listed with the specification of the range of the average alkoxylation representing the no-longer polymers.

The range of the average alkoxylation has been identified assuming a symmetric disposition of the monomer units with equal length of the propagating chains.

 - 3.2) OLIGOMERIC REACTION PRODUCTS

The oligomeric reaction products are described by their starting materials.  However, to be in accordance with the nomenclature used for EINECS [i.e. IUPAC nomenclature for well defined substances, CAS nomenclature for UVCB's (substances of unknown or variable composition, complex reaction products or biological material)], the components of the oligomeric reaction products are named using IUPAC nomenclature for well defined substances and CAS-style nomenclature for UVCB's, e.g.:

4,4'-Isopropylidenediphenol, oligomeric reaction products with I-chloro-2,3-epoxypropane, reaction products with cyclohex-1,2-ylenediamine

In the no-longer polymers which contain a structural unit which has polymer-like characteristics, the latter unit is identified by using the prefix "poly" in the name or using names represented by the structural repeating units, e.g.:

Polymethylenepolyphenylene polyisocyanate, oligomeric reaction products with 2,2-bis(bromomethyl)propane-1,3-diol, polyethoxylated and polypropoxylated glycerol grafted with acrylonitrile and styrene, toluene diisocyanate and alpha,alpha',alpha"-1,2,3-propanetriyltris[omega-
hydroxypoly[oxy(methyl-1,2-ethanediyl)]]

 - 3.3) OLIGOMERS FROM ONE MONOMER ONLY

Homopolymers submitted which represent no-longer polymers are named as oligomers e.g.:
 - Styrene, oligomers
 - 4,4'-Methylenediphenyl diisocyanate, oligomers

 - 3.4) DIMERS AND TRIMERS

Substances representing dimers and trimers, as well as their reaction products, are considered No-Longer Polymers.  They are listed as e.g.:

Fatty acids, C18-unsatd., dimers
Fatty acids, C18-unsatd., dimers, reaction products with...

 - 3.5) POLYMER-LIKE SUBSTANCES CONTAINING 50% OR MORE BY WEIGHT OF SPECIES WITH THE SAME MOLECULAR WEIGHT

These substances have the appearance of polymers because they contain 50% or more by weight of species with the same molecular weight.  By definition they are no-longer polymers.  In the list, they are labelled accordingly.

The use of the prefix "poly" in the chemical description of the substance does not mean that it is a polymer in the sense of the 7th Amendment.  Only the definition given above is of importance.

There exist different types of them, exemplified as follows:

a) * Poly(oxy-1,2-ethanediyl), alpha-butyl-omega-hydroxy
* Poly(1,1,2,2-tetrafluoro-1,2-ethanediyl),alpha-fluoro-omega-2-
 [3-((carboxylatomethyl)dimethylammonio)propylaminosulfonyl)ethyl

b) * Butene, homopolymer (products derived from either/or But-1-ene/But-2-ene)
* Propene, homopolymer, reaction products with maleic anhydride,
monomethyl ester, lanthanum salts

c) * Formaldehyde, polymer with aniline, reaction products with maleic anhydride
* Adipic acid, polymer with hexane-1,6-diol and propylidynetrimethanol

4) SPECIAL NOMENCLATURE RULES

The explanations given in the following may differ from other recognized nomenclature rules.

 - For substances listed in the no-longer polymer list with an "alkyl range", the chains are assumed to be "straight-chain and saturated" unless qualified with terms such as "branched", "iso", "unsaturated", or "branched and linear ", e.g.:

Alcohols, Cl2-15, ethoxylated
Alcohols, C12-15-branched, ethoxylated
Alcohols, C12-15-branched and linear, ethoxylated

 - Compounds with an alkyl range in the name represent substances which are substituted by an alkyl group with a chain length with each alkyl present in the range.  The alcohols listed above have a chain length of C12, C13, C14, and C15.
Each alkyl derivative is present and the degree to which each derivative is present in the substance
is unknown.
Therefore broader alkyl ranges do not cover narrower ones or individual ones.

 - Fatty acids listed as components in the no-longer polymer list are specified by the source, or the specific alkyl or alkyl range, e.g.:

Fatty acids, tall-oil, oligomeric reaction products with...
Fatty acids, C16-18 and C18-unsatd., oligomeric reaction products with...

Fatty acids listed as components in the no-longer polymer list with an alkyl range and without any other specification represent straight chain saturated fatty acids.

 - 80% RULE:

Mixture of oligomers or isomer mixtures are generally listed in the no-longer polymer list with the name of the main component only when present in the mixture with 80% or more.  Thus dimer acid reported as fatty acids, C18-unstd.  with 80% dimers, 15% trimers and 5% higher oligomers is listed in the no-longer polymer list as:

Fatty acids, C18-unsatd., dimers, etc.

The names listed in the no-longer polymer list result from the information given on the reporting forms.  No interpretation of the forms has been made.
For disagreements with reported data, problem letters were issued in order to ensure the correct names of the reported substances.

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The EU Priority Lists

The EU has been concerned about the potential risks of chemicals to the human health and the environment since the late 1980s (The Council of the European Communities, 1986. Fourth Community Action Programme on the Environment (1987-1992). Office of Official Publications of the European Communities, Luxembourg).  As a result, the European Commission proposed a series of legal instruments, which were aimed at meeting the objectives outlined in the Action Programme.

One of these instruments was the so-called 'Existing Substances Regulation', Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances which foresees that the evaluation and control of the risks posed by 'existing chemicals' (i.e. those in EINECS) will be carried out in four steps:

            STEP I -> Data collection;
            STEP II -> Priority setting;
            STEP III -> Risk assessment;
            STEP IV -> Risk reduction.

Article 8 of the Regulation states that the Commission, in consultation with the Member States, will regularly draw up lists of priority substances which require immediate attention because of their potential effects to man or the environment.

Substances on priority lists must be subjected to a detailed risk assessment covering the risks posed by the chemical to man (covering workers, consumers and man exposed via the environment) and the environment (covering the terrestrial, aquatic and atmospheric ecosystems and accumulation through the food chain).  Initial versions of the risk assessment reports are written by the Member States which act as "rapporteurs".

Since 1994, four such priority lists have been published and are embodied in the following regulations:

Commission Regulation (EC) No. 1179/94 of 25 May 1994 concerning the first list of priority substances as foreseen under Council Regulation (EEC) No 793/93 (OJ No. L 131, 26/05/1994 p. 3-4);
Commission Regulation (EC) No. 2268/95 of 27 September 1995 concerning the second list of priority substances as foreseen under Council Regulation (EEC) No 793/93 (OJ No. L 231, 28/09/1995 p. 18-19), subsequently corrected by OJ No. L 237, 06/10/1995, p. 8;
Commission Regulation (EC) No. 143/97 of 27 January 1997 concerning the third list of priority substances as foreseen under Council Regulation (EEC) No 793/93 (OJ No.L 25, 28/01/1997 p. 13-14);
Commission Regulation (EC) No 2364/2000 of 25 October 2000 concerning the fourth list of priority substances as foreseen under Council Regulation (EEC) No 793/93 (OJ No. L 273, 26/10/2000 p. 5-7).

In the main EINECS Plus inventories, the substances on these lists are now indicated in the Database or List identifier field (DB) with their own identifiers of either EUPL1, EUPL2, EUPL3 or EUPL4.  Furthermore, the Member State(s) Responsible for Risk Assessment field (RAP) exists to allow users to further limit searches.  Please refer to these fields for example searches in the present context.

Details on the status of the Risk Assessment for priority substances can now be obtained directly from EINECS Plus by using a new link feature.  Click here for more information.

More information regarding the Priority Lists and risk assessment can be found at the European Chemicals Bureau website as well as in the full text legislative database, 'A summary of EU legislation on dangerous substances and preparations', included elsewhere in the EINECS Plus compendium.

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The EU Indicative Occupational Exposure Limits

Indicative occupational exposure limit values have long been recognised as a key part of the overall approach to ensuring the protection of the health and safety of workers at the workplace, against the risks arising from hazardous chemicals.

Commission Directives 91/322/EEC, 98/24/EC and 2000/39/EC establishing lists of binding and indicative occupational exposure limit values in implementation of Council Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work, are practical steps to help protect workers from chemical risks at Community level.

This exposure limit data is included in the main EINECS Plus inventories in the European Union Threshold Limit Values (TLV) field to which the reader is directed for further information on data retrieval and presentation.  In addition, where such data exists, it is noted also in the Database or List identifier field (DB) with the identifier EU-OEL.  The data is available in English, French, German, Dutch, Italian, Spanish, Portuguese and Danish and integrated into EINECS records wherever possible.

Important reasons for publishing the exposure limit data include the need to establish short-term exposure limit (STEL) values for some agents and to publicise the fact that some agents can penetrate the skin.  This information is included in the European Union Threshold Limit Values (TLV) field.

It should be noted that for any chemical agent for which indicative occupational exposure limit values are established at Community level, Member States are required to establish a national occupational exposure limit value, taking into account the Community limit value and determining its nature in accordance with national legislation and practice.

Furthermore, for any chemical agent for which a binding exposure limit value is established, Member States shall establish a corresponding national binding occupational exposure limit value based on, but not exceeding, the Community limit value.  Currently, there is only one such binding limit which is for inorganic lead and its compounds; all other limits are indicative.

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Chemicals Subject to the International PIC (Prior Informed Consent) Procedure

Some of the text below has been taken from guidance documentation from the European Chemicals Bureau and this is dutifully acknowledged.

The aim of the Convention or Procedure of Rotterdam is to promote shared responsibility and co-operative efforts among the Parties in the international trade of dangerous chemicals in order to protect human health and the environment from potential harm and to contribute to their environmentally sound use.  It is mainly based on the non-legally binding provisions of the London Guidelines for the Exchange of Information on Chemicals in International Trade of the United Nations Environment Programme (UNEP), as amended in 1989, and on the International Code of Conduct on the Distribution and Use of Pesticides, as amended in 1990, of the Food and Agriculture Organisation (FAO).  Those provisions provided for a voluntary PIC procedure, which is already being applied on a voluntary basis by more than 165 countries.  The European Community has participated in these arrangements and made the voluntary procedure legally binding through Council Regulation (EEC) No 2455/92, which has now been replaced by Regulation 304/2003 (subsequently amended by Commission Regulations 1213/2003 and 775/2004).  In accordance with the resolution on interim arrangements adopted by the September 1998 Ministerial Conference when the Convention was opened for signature, the previous voluntary procedures, modified as necessary, were subsumed in those interim arrangements so that the Convention rules could be applied voluntarily in advance of entry into force.  The European Community has been participating fully in this transitional system.

The basic principle of the Convention is that the export of a banned or severely restricted chemical which is included in Annex III to the Convention can only take place with the prior informed consent (PIC) of the importing Party.  A procedure is established for formally obtaining and making known the decisions of importing countries as to whether they wish to receive future shipments of a certain chemical and for ensuring compliance with these decisions by exporting countries.  The Convention establishes a mechanism for including further substances, provided that certain criteria are met.

The trigger for inclusion of a chemical in the process is that Parties must notify the Secretariat of all final regulatory actions banning or severely restricting a chemical falling within the scope of the Convention.  After notifications from at least two Parties belonging to different geographic regions defined by the Conference of the Parties (CoP) under the Convention have been submitted to the Secretariat, the information will be evaluated by a subsidiary body, the Chemical Review Committee (CRC), composed of government-designated experts in chemicals management.  If the relevant criteria are met, the CRC drafts a decision guidance document (DGD) and recommends to the CoP that the chemical be included in the PIC procedure.  The CoP then decides whether or not the chemical will be so included.  The DGD is then circulated to all Parties providing information to enable them to take an informed decision whether to accept or refuse import, or to allow import under certain conditions.  Every six months the Secretariat informs all Parties of the responses received (the so-called “PIC circulars”), which are also listed on the PIC website at http://www.pic.int/. Exporting parties are obliged to ensure that their exporters comply with any import decisions.

The other key pillar of the Convention relates to the exchange of information among Parties about potentially hazardous chemicals that may be exported and imported.  The main provision in this regard is the requirement that a Party that plans to export a chemical that is banned or severely restricted for use within its territory, must inform the importing Party that such export will take place, before the first shipment and annually thereafter (the so-called “export notification” procedure) until the chemical becomes subject to the PIC procedure and the importing party has provided an import response for the chemical which has been distributed to the Parties.  In addition, the exporting Party must require that exports of chemicals included in the PIC procedure are subject to labelling requirements that ensure adequate availability of information with regard to risks and/or hazards to human health or the environment.  It may also impose similar requirements for exports of other chemicals that are banned or severely restricted domestically.

The Convention also contains provisions relating to technical assistance between Parties.  Parties with more advanced programmes for regulating chemicals should provide technical assistance, including training, to others such as developing countries to help them develop their infrastructure and capacity to manage chemicals.

As of 19 March 2004, there were 73 signatories to the Convention and 63 parties had ratified.  The European Community ratified on 20 December 2002 (Council Decision 2003/106/EC of 19 December 2002 (OJ L 63 6.3.2003, p. 27)).  The Convention entered into force on 24 February 2004.

Regulation (EC) No 304/2003 was adopted on 28 January 2003, and came into force on 7 March 2003.  It replaced Regulation (EEC) no. 2455/92, which was repealed.  The objectives of the regulation are:
 (i) to implement the Rotterdam Convention  (in some cases going beyond its provisions);
 (ii) to ensure that the provisions of Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances, and of Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations, regarding the classification, packaging and labelling of chemicals dangerous to man or to the environment when they are placed on the market in the European Community shall also apply to all such chemicals when they are exported from the Member States to other Parties or other countries, unless these provisions would conflict with any specific requirements of those Parties or other countries.

The Regulation covers:
- Chemicals subject to the PIC procedure (PIC list);
- Chemicals that are banned or severely restricted within the Community;
- All chemicals when exported so far as packaging and labelling is concerned.

The Regulation does not apply to chemicals that are drugs, radioactive materials, wastes, chemical weapons, food and food additives, feeding stuffs, genetically modified organisms, pharmaceuticals (except disinfectants, insecticides and parasiticides), as defined in other Community legislation. Nor does it apply to chemicals for research or analysis provided that the quantities are not likely to affect human health or the environment and are in any case not more than 10 kg.

It is important to note that the PIC list reintroduced in Regulation (EC) No 304/2003 has been modified twice by regulations 1213/2003 of 7 July 2003 (OJ L 169 8.7.2003, p. 27) and 775/2004 of 26 April 2004 (OJ L 123 27.4.2004, p. 27).

It is further important to note that ONLY the PIC list is currently present in EINECS Plus.

More information about PIC can be found at http://ecb.jrc.it and http://www.pic.int.

EINECS Plus Implementation Notes

In the main EINECS Plus databases, the Database or List identifier field (DB) carries an identifier (which is PIC) if the chemical is on the PIC list.  To reveal the entire PIC list, type db=pic at the search prompt and 34 records will be returned.  If the chemical or chemical group is also subject to an export ban (Article 14 of Regulation 304/2003) an additional identifier (PICBAN) is present and the name of the chemical or group is asterisked (*).

The PIC list DOES NOT contain the entire list of chemicals and articles subject to an export ban - this is currently beyond the scope of EINECS Plus.

Please note that where multiple CAS numbers are given, the list may not be complete and may only be an indicative list.

Where possible, EC numbers have also been given as an aid to the end user (they do not appear in the PIC list in Regulation 304/2003 although they were cited in earlier versions of the PIC list in EU legislation).  As with CAS numbers, where more than one EC number is present, the list may not be complete and may only be an indicative list.  Also, certain EC numbers may not precisely describe individual PIC substances (e.g. Asbestos fibres; the 'closest' matching EC number is 310-127-6 yet the EINECS name is "Naturally occurring substances").  Please further note that the PIC records have not been linked with EINECS records - these sets of records are mutually exclusive.

Included in PIC list records are Combined Nomenclature codes (CNC field).  Sometimes the (8-digit) code ascribed to the record may cover a group of substances rather than the single PIC substance.  In such cases the string 'ex ' precedes the code.  Sometimes, the CN codes may apply to individual substances covered by the PIC name rather than the PIC name in its entirety.

This implementation also includes the PIC use category (PIC field).

The PIC list is presented in English, French, German, Dutch, Italian, Spanish, Portuguese, Danish, Swedish and Finnish.

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About ECICS

ECICS (European Customs Inventory of Chemical Substances) is the tariff classification of chemicals in the Combined Nomenclature of the EC, developed by Directorate-General Taxation and Customs Union of the Commission of the European Communities.

ECICS 2000 contains 29284 products in all Community languages (with the exception of Greek which is omitted for technical reasons), together with their tariff classifications in the European Community's Combined Nomenclature (CN, 8-digit classification codes).  The CN is based on the "Harmonized Commodity Description and Coding System" which is used worldwide.  This version of ECICS embodies Commission Regulation (EC) No 2204/1999 of (OJ L 278, 28.10.1999) amending Annex I to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff.

Substances in ECICS are identified by their CAS number (which is present in nearly all records).  Where this is not available a CUS (Customs Union and Statistics) number exists which is assigned internally by the Directorate-General Taxation and Customs Union and which acts as a link between the various language-versions of the Inventory and the CAS number.  There are also Preferred name and Synonym(s) fields.  The crucial Combined Nomenclature code is also present in every record and the original ECICS data has been significantly enhanced by adding EC numbers where possible from the EINECS/ELINCS records.

As with the EINECS records, additional fields have been added  to facilitate retrieval.  These are the Language of record and Database or List identifier fields.

The types of substances included in the database are:

1.  all pesticides and other plant-protection products named by the International Organization for Standardization (ISO) in the International Standard ISO 1750 (approximately 500 products);
2.  all International Nonproprietary Names (INN) allocated by the World Health Organization (WHO) for pharmaceutical substances and contained in the Proposed INN lists Nos 1 to 80 (approximately 6900 products);
3.  salts and esters of INNs (approximately 1000 products), called INNM ("M" means "modified");
4.  pharmaceutical intermediates, i.e. compounds used for the manufacture of finished pharmaceutical products (approximately 900 products);
5.  narcotic drugs, psychotropic substances and their precursors (approximately 300 products);
6.  chemical substances which deplete the ozone layer (approximately 270 products);
7.  toxic/dangerous chemicals controlled by the Chemical Weapons Convention (approximately 65 products);
8.  other products, subject to import/export controls;
9.  other products, of commercial interest.

Typical users of the ECICS data include those involved in international trade (such as importers, exporters, customs agents, customs administrations and statistical offices), as well as specialists (such as chemists, translators and scientific editors).  ECICS is also available to the general public at large.  Contact the Office for Official Publications of the European Communities for further information.

The database is updated on an annual basis.  This task involves identifying products submitted to export/import controls and new products (as a result of requests of trade associations or national and Community authorities or for legal reasons) of commercial significance together with their tariff classifications.

The inventory lists numerous chemical products commonly traded internationally and indicates their correct classification in the Combined Nomenclature of the European Communities.  In general, the inventory does not cover mixtures or preparations.

ECICS does not include the current duty rates, but rather provides a simplified access to the CN Code for chemical substances.  These codes can then be used to find the valid duty rates from the current TARIC database maintained by the European Commission.  The TARIC database is updated on a daily basis to reflect tariff suspensions, preferences, quotas, etc., and this information is supplied directly to the Member States.

The ECICS records are displayed as individual records and are not added to EINECS/ELINCS or ANNEX I records.  However, loading the EINECS database set gives access to records from both EINECS and ECICS.  Substance information from ECICS is best searched for using either the CAS Number or the EC number of the substance.

As ECICS is also available in Swedish and Finnish, it is a good source of translated chemical names in these languages.

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The Harmonized Commodity Description and Coding System (HS) and ECICS

Goods need to be classified for customs and statistical purposes.  In the past it was decided to have a single “nomenclature” (i.e. classification system) in order to meet both customs and statistical requirements.  This decision was implemented by the adoption of the Council Regulation (EEC) No 2658/87.  Thus, on January 1, 1988 the Community introduced the concept of the Combined Nomenclature (CN) with a view to facilitating trade and the collection and exchange of statistical data of European Community external trade.

In its broadest sense, the HS is a classification of all physical objects (including electricity); it does not cover services.  It is composed of the following legally binding elements: general rules for the interpretation of the HS, section and chapter notes, code numbers and the text of the classification (including indents).  None of these elements is to be considered in isolation; indeed, the precise significance of some of the entries can be understood only in relation to the section and chapter notes.  In addition to the legally binding elements of the HS, there are also explanatory notes, which are not legally binding but are useful in interpreting the classification.

The CN, on the other hand, is based on the HS nomenclature, which is used worldwide, and the Community, as a contracting party to the HS Convention, is under an obligation to follow the structure of that nomenclature using the headings and subheadings of the first 97 chapters.  (The HS has the legal status of an international convention and is, like the CN nomenclature, a customs and statistical nomenclature established to facilitate international trade and the collection, comparison and analysis of statistics applicable to such trade).  The CN is the European Community's classification of goods, which meets requirements in terms of external trade statistics (both intra- and extra- EC) and the customs tariff within the meaning of Article 9 of the Treaty establishing the European Economic Community.

The HS is a 6-digit nomenclature.  See the example below, taken from Chapter 29 “Organic chemicals”.

H. S. Code
29.37
Hormones, natural or reproduced by synthesis; derivatives thereof, used primarily as hormones; other steroids used primarily as hormones:

The CN is an 8-digit nomenclature.  The Common Customs Tariff (CCT) of the EC, which is based on the CN, incorporates the duty rates.  The CCT basically reflects the legal situation with regard to customs duties applied on a permanent basis.  See below the CCT structure for the same example which has been treated above (hormones).  In the list that follows data items are separated by the "#" character and are the description, rate of autonomous duty (%), the rate of conventional duty (%) and the supplementary unit.

CN 2000 Code
2937 Hormones, natural or reproduced by synthesis; derivatives thereof, used primarily as hormones; other steroids used primarily as hormones:

The most common problem facing parties responsible for providing information is finding the right code number (classification) for the goods that are being exported or imported.  In this context, it must be remembered that estimates of the total number of goods in existence range between 50 million and 100 million.  The CN, however, contains only about 10000 subheadings, each of which therefore comprises a grouping of goods.  The general problem is therefore to place a given goods item in the right grouping (corresponding to the 8-digit code), which almost always means that there is a choice between two or sometimes more possibilities.

It is noteworthy that TARIC (the Integrated Customs Tariff of the European Communities), which contains further subdivisions to the CN, was established to deal with certain specific Community measures (like the Generalized System of Preferences (GSP) or other tariff arrangements of a non-permanent nature) which could not be dealt within the framework of the CN nomenclature itself.

A complete version of the annex to the Regulation on the tariff and statistical nomenclature and on the Common Customs Tariff is published annually, and usually not later than 31 October, in the Official Journal of the European Communities (Article 12 of Council Regulation EEC No 2658/87).  The annex is applicable on 1 January of the following year.

The Combined Nomenclature and ECICS

Numerous chemical products move into and out of the Community.  These chemicals have to be charged with duty, if they are dutiable, or their eligibility for duty exemption or relief has to be established if they come under duty free or reduced duty categories.  Furthermore, detailed trade statistics are collected, not only for governmental purposes but also for the benefit of producers and traders who keep a close watch on external trade flows.  Thanks to the statistics, it is possible to control the trade and to fight against unacceptable trade procedures (dumping, for example).

Chemical products which are commonly traded internationally are classified for customs and statistical purposes within the framework of the Combined Nomenclature descriptions and codes above.

The customs declarations are set up by clerks in the offices of forwarding agents, and then checked by customs officials who do not always have the benefit of a expertise in chemistry.  Clearly then, customs clearance of chemicals creates problems.

The objective of the inventory is quite specific and simple, namely to facilitate the task of importers and exporters of chemicals and of the customs staff who have to process declarations.

In order to meet this objective ECICS was developed by the European Commission:

 - to identify unequivocally each chemical commonly traded internationally for customs and legal purposes;
 - to establish for each chemical a name as brief and as simple as possible;
 - to have names which are as similar as possible in the various languages.

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The Official Journal of the European Communities (OJ)

The full texts of all European Community legislation directly or indirectly associated with EINECS Plus are published in the OJ.  Only the texts published in the paper edition of the OJ are deemed authentic.  In certain circumstances, however, (and only when it is clear beyond any doubt that a printing mistake exists in the paper or electronic version of the OJ), corrections may be made in this product.

Subscriptions to and issues of the OJ, as well as copies of individual texts, may be ordered from the publishers, the Office for Official Publications of the European Communities at the address below, and from its sales agents in the Member States of the European Union and elsewhere.

Office for Official Publications of the European Communities (EUR-OP)
2 rue Mercier
L-2985 Luxembourg

email: info-info-opoce@cec.eu.int;opoce-info-info@cec.eu.int

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The List of National Competent Authorities

The European Commission's role is essentially to coordinate the notification scheme as established by the 6th and 7th amendments.  The Commission does not respond to enquires from industry; these are handled by the relevant Competent Authorities in each of the Member States.  Notification dossiers are submitted to the Competent Authority in the Member State where the substance will be placed on the market.  All communications concerning new notifications, sharing of data from existing notifications or requests for information on the notification procedures must be addressed to the relevant Competent Authority.

The following list contains the contact details for the Competent Authorities in each Member State.  Although not a Member State, Norway has similar notification requirements to those in the EU and therefore details of the Norwegian Competent Authority are also included.  This list will help save time when looking for information on the Notification Procedures.

A Competent Authority (CA) is the principle administrative organisation representing Member State government, and responsible for implementation of relevant policy established as national and EU legislation.  The executive jurisdiction of CAs is wide in overall scope.

Notification units (NU), on the other hand, are departments within CAs, and subsidiary to a CA, responsible for implementation of the new chemicals notification scheme as established by Directive 67/548/EEC and related legislation including subsequent amendments.  NUs generally have one address, whilst CAs may have multiple addresses.

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The New Chemical Substances Notification Units in the European Union and Norway

The following contact points should be used for submissions to the ELINCS inventory.  Notification Units are not to be confused with Competent Authorities.  Click here for an explanation.

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Fields in EINECS Plus

Each record in EINECS Plus contains a series of fields (please consult the general Help Index/Contents for more information on records and fields).  The full list of possible fields appears below.  Click on the long field name to see a definition of the field with an example of how to use it in searching (if appropriate).

Highlighted fields are limit fields.  Asterisked (*) fields are not searchable.

There is also a special subset of fields, Citation (CITN), which consists of the EC, CAS, LA, PN, SY, TN, IDX, NAML, REV, CNC and DB fields. Use the citation to display, print, or save only these fields for a set of records.

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Inter-database record linkage and special sets of records

Most records in ANNEX I link unambiguously and directly to either an original EINECS record or an original ELINCS record and in these cases the link has been made via the single EC number to produce a single, seamless and composite record.

However, there are some records in ANNEX I which either contain multiple EC numbers or none at all.  The former case gives rise to additional records of type DDS (see the Related record note and Database or List identifier fields) which reveal 1-to-1 links between the individual discrete substances in such ANNEX I records.

Thus, linkage between EINECS and ANNEX I and between ELINCS and ANNEX I has been attempted wherever possible, in order to maximize integration between the distinct yet strongly related data sources.

In addition there are some records which contain no EINECS/ELINCS numbers and which are all associated with Note A as each resulting record actually maps implicitly to many different substances.  To reveal these records, do the following search: db=ds not db=ei not db=el and note a in nt.  Most records in this hit-list make a references to many substances implicitly in EINECS or ELINCS.  As an example, sodium cyanide exists in an original EINECS record but not explicitly in ANNEX I.  Rather, it is covered by the ANNEX I entry with index number 006-007-00-5 and with a labelling name of "hydrogen cyanide (Salts of ...) with the exception of complex cyanides such as ferrocyanides, ferricyanides and mercuric oxycyanide".

There is a set of records which exists with two or more entries in ANNEX I (with the same EC number) and only one in EINECS.  These are listed below (EINECS number first, name in brackets)and are accompanied by the presence of the Related record note (RRN) field alerting you to this fact:

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Search examples and notes on retrieval

Example 1: How do I find all dangerous substances which can be described as halogenated hydrocarbons and which are 
extremely flammable ?
Answer 1: extremely flammable in id and 602 in sc
Note that you do not need to restrict searching to ANNEX I (db=ds) as the SC and ID fields occur only in ANNEX I.

Example 2: Which EINECS records containing silicon are also in ANNEX I and are corrosive ?
Answer 2: si* in mf and c in si
Note that this search will not work for ELINCS as there are no chemical or molecular formula data in ELINCS at 
present.

Example 3: Which amine compounds are irritants and should be kept away from children ?
Answer 3: 612 in sc and children in saf and xi in si
Note the use of the Annex I substance code.  You can also use the SI field in this case as the symbol is not F+ or T+.

Example 4: Which ketones or ketone derivatives in ELINCS are dangerous for the environment ?
Answer 4: 606 in sc and db=el and n in si
See the comments for example 3.

Example 5: I would like to know the dyestuffs and/or pigments - which are in the Official Colour Index (CI) - and are 
also in Annex I ?
Answer 5: ((ci or c.i.) in znf, naml) and ((db=ds) or (db=dds))
As full-stops are indexed in the PN and SY fields but not in TN or NAML fields both "ci" and "c.i." are used in the 
search.  Also, both ci and c.i. appear in ELINCS.  Note the use of parentheses for clarity.

Example 6: My employers would like to market a new product, known as SP-ALCOHOL, throughout the Community.  I suspect 
that other companies may have synthesized this and used it internally, but does it already exist in EINECS or ELINCS ?
Answer 6: sp-alcohol in znf, naml
This search actually results in no hits across EINECS Plus but is nevertheless a significant, albeit, hypothetical 
search to do.  If SP-ALCOHOL was already on the market, the new manufacturer or importer could, under certain 
circumstances, refer to the information in the original technical dossier when notifying the competent authorities 
of its intention to place SP-ALCOHOL on the market.  On the other hand, if SP-ALCOHOL was NOT in EINECS or ELINCS, 
the manufacturer/importer would have to present a full pre-marketing notification dossier to the competent authority 
in the country or countries where the product was to be placed on the market.  If the CAS number is available, it 
would be more efficient to carry out the search using this number.

Example 7: What is the CN99 code for acetone in the ECICS database ?
Answer 7: acetone- in znf and db=tci
Note that if the hyphen is omitted from this search, all ECICS records containing the term acetone will be retrieved 
and not the single record of interest.  Note also the use of the Name fragments field which automatically searches 
BOTH the Prime name and Synonym(s) fields as the term could feasibly appear in either field.  Ensure that the CNC 
field is displayed (it is by default) - the answer is 2914 11 00.  Note the use of the DB field to exclude records 
from EINECS, ELINCS etc.

Example 8: Is aniline in ECICS ?
Answer 8: aniline- in znf and db=tci
Note again the use of the hyphen and the Name fragments field.  See example 7 above as well.

Example 9: I have the CAS number for chlorobenzene (108-90-7) and I know it is in ECICS but need to find the Swedish 
translation for this chemical.  How do I do this ?
Answer 9: 108-90-7 in rn
You must load the ELINCS 7 provisorisk/ECICS+ 2004:1:SV database.  Ensure that the Prime name field is displayed 
(it is by default).  The answer is klorobensen.

Example 10: How do I find all the exposure limit data in EINECS Plus ?
Answer 10: eu-oel in db
Every record featuring an exposure limit, whether it be binding or indicative, short term or an eight hour average 
will be obtained by the above search, regardless of whether the substance is in EINECS or ELINCS.

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Using limit fields

Limit fields, when combined with other search terms, are particularly useful for focusing or limiting a search.  To search a limit field, use the in (followed by the field abbreviation) or = (preceded by the field abbreviation) operators, as in:

50-00-0 in cas
082* in idx
rev=20n
la=en and db=dds

Omitting the field label retrieves information from free text (non-limit) fields only.  Note that truncation and wild-cards are permitted with the 'in' operator.

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Using the indexes for searching

There are several indexes in EINECS Plus.  Limit-term indexes are available for the EC, NY, TOTN, CAS, LA, IDX, SC, REV, CNCS, RAP and DB fields.  All other indexable words from the other fields are in the free-text index.

The Index function provides a mechanism for accessing these indexes in EINECS Plus.  You can use this function to select search terms from any of these indexes.  The text below applies to the WinSPIRS interface.  Similar comments apply to the WebSPIRS interface.

As an example, let us start with the word coal:

1. Click the Index button on the button bar or select Index from the Views menu in the Search screen.
2. Type coal in the Index: text entry area of the Index screen.  The alphabetical list of terms scrolls down to match your term.  You will see other potentially useful terms related to coal such as coal-derived, coal-petroleum, coal-tar, etc.
3. Click the Show button to display the records associated with the term.

To use index terms in your search:

1. Select one or more terms.  To select multiple terms, hold down the [Shift] or [Ctrl] key and click on the desired terms, or hold down the mouse button and drag the pointer over the desired terms.
2. Click the Search button.  The terms appear in the Search History area of the Search screen.  If you have selected multiple terms, WinSPIRS combines them with the "or" operator.

Thus the index function is useful in potentially narrowing your search, suggesting other related terms and as a check on spelling and will always result in a non-zero hit list.

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Using accented and other special characters in searching

EINECS Plus contains data in English, French, German, Dutch, Italian, Spanish, Portuguese, Danish, Swedish and Finnish and many of these languages contain accented characters in their alphabet.

All words containing accented characters are displayed as such in both WinSPIRS and WebSPIRS.  For the former, you may need to choose a font other than the default font if it does not support the ISO 8859-1 (Latin alphabet No. 1) character set (known elsewhere in this guide as ISO Latin-1) for display/printing.  All words containing accented or foreign characters (as well as a to z and A to Z) are converted to their upper case equivalents and then indexed as such.  The collating sequence chosen for all indices in all languages is that for ISO Latin-1 except that all terms beginning with a numeric character appear at end.  This has been done to provide ease and consistency in a multi-lingual and multi-database (i.e. when two or more databases from different languages are selected for retrieval) environment.

The actual collating sequence or character order in all indices is:

-, ., A, B, C, D, E, F, G, H, I, J, K, L, M, N, O, P, Q, R, S, T, U, V, W, X, Y, Z, À, Á, Â, Ã, Ä, Å, Æ, Ç, È, É, Ê, Ë, Ì, Í, Î, Ï, Ñ, Ò, Ó, Ô, Õ, Ö, Ø, Ù, Ú, Û, Ü, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 0.

Note that the hyphen (indexed in all searchable fields) and full-stop (indexed in certain fields where the full stop is significant, e.g. the Prime name or Chemical or molecular formula fields) are also included in the list at the start.  No other characters are indexed but can be included in searches (the search engine will strip them out if necessary before attempting a search).

The German ß character is not used and the 2-character combination "ss" is used instead.  Also, in French and Italian data the apostrophe is treated like a space character in that if it appears in a phrase, the constituent parts of a phrase are separated and indexed separately, e.g. d'oxyde, l'oxyde and oxyde will all index under "oxyde" ("d" and "l" will be indexed too).  This means that chemical names containing apostrophes in these languages will index somewhat differently than in the other languages and that lateral searching of phrases containing these apostrophes will not work (e.g. change d'oxyde to d oxyde).

Greek characters also exist in the raw chemical name data used for EINECS Plus.  These are replaced by their native language word equivalents.

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Stopwords

In general, some words appear too frequently in databases to be useful for searching; these are known as stopwords.

Owing to the multilingual nature of EINECS Plus, there are NO stopwords in any of the databases.  This allows complete searching of all common words in phrases.

Note that words such as "in", "and", "or", "not", "near" and "with" which form part of a search phrase, should be placed in double quotes when searching any of the databases in this compendium, as they are search operators.

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Lateral searching

You can select search terms from displayed records and then search for them directly, without having to retype them; this is called "lateral searching" (WinSPIRS only).

To search laterally:

1. Select a term from the record display area of the Search or Index screen by dragging across or double-clicking on the term.  WinSPIRS highlights the term.

2. Click the Add to Search button.  If necessary, WinSPIRS switches to the Search screen.  The term is then copied to the Search: text entry area of the Search screen.

3. Click the Search button to search for the term.

In WebSPIRS just select and copy the text and then paste it into the search area.

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Notes about labelling of preparations

The following is the list of concentration notes relating to the labelling of preparations that appear in some ANNEX I records.

NOTE 1:

The concentration stated or, in the absence of such concentrations, the general concentrations of Directive 1999/45/EC are the percentages by weight of the metallic element calculated with reference to the total weight of the preparation.

NOTE 2:

The concentration of isocyanate stated is the percentage by weight of the free monomer calculated with reference to the total weight of the preparation.

NOTE 3:

The concentration stated is the percentage by weight of chromate ions dissolved in water calculated with reference to the total weight of the preparation.

NOTE 4:

Preparations containing these substances have to be classified as harmful with R 65 if they meet the criteria in section 3.2.3 in Annex VI.

NOTE 5:

The concentration limits for gaseous preparations are expressed as volume per volume percentage.

NOTE 6:

Preparations containing these substances have to be assigned R 67 if they meet the criteria in section 3.2.8 in Annex VI.

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Notes concerning the identification/classification/labelling of substances

The following is the list of notes relating to the identification and labelling of substances that appear in some ANNEX I records.

NOTE A:

The name of the substance must appear on the label in the form of one of the designations given in Annex I (see Article 23 (2) (a)).

In Annex I, use is sometimes made of a general description such as "...compounds" or "...salts". In this case, the manufacturer or any other person who markets such a substance is required to state on the label the correct name, due account being taken of the chapter entitled "Nomenclature" of the Foreword:

Example:  for BeCl2 (Einecs No 232-116-4):  beryllium chloride.

The Directive also requires that the symbols, indications of danger, R- and S- phrases to be used for each substance shall be those shown in Annex I (Article 23 (2) (c), (d) and (e)).

For substances belonging to one particular group of substances included in Annex I, the symbols, indications of danger, R- and S- phrases to be used for each substance shall be those shown in the appropriate entry in Annex I.

For substances belonging to more than one group of substances included in Annex I, the symbols, indications of danger, R- and S- phrases to be used for each substance shall be those shown in both the appropriate entries given in Annex I. In cases where two different classifications are given in the two entries for the same hazard, the classification reflecting the more severe hazard classification is used.

Example:

for substance AB - no individual entry in Annex I:

Annex I group entry for compounds of A:
- Repr. Cat. 1; R 61
- Repr. Cat. 3; R 62
- Xn; R 20/22
- R 33
- N; R 50-53

Annex I group entry for compounds of B:
- Carc. Cat. 1; R 45
- T; R 23/25
- N; R 51-53

Classification of substance AB thus becomes:
- Carc. Cat. 1; R 45
- Repr. Cat. 1; R 61
- Repr. Cat. 3; R 62
- T; R 23/25
- R 33
- N; R 50-53

NOTE B:

Some substances (acids, bases, etc) are placed on the market in aqueous solutions at various concentrations and, therefore, require different labelling since the hazards vary at different concentrations.

In Annex I entries with Note B have a general designation of the following type: "nitric acid ...%".

In this case the manufacturer or any other person who markets such a substance in aqueous solution must state the percentage concentration of the solution on the label.

Example : nitric acid 45%

Unless otherwise stated, it is assumed that the percentage concentration is calculated on a weight/weight basis.

The use of additional data (e.g. specific gravity, degrees Baumé) or descriptive phrases (e.g. fuming or glacial) is permissible.

NOTE C:

Some organic substances may be marketed either in a specific isomeric form or as a mixture of several isomers.

In Annex I, a general designation of the following type is sometimes used: "xylenol"

In this case the manufacturer or any other person who markets such a substance must state on the label whether the substance is a specific isomer (a) or a mixture of isomers (b).

Example:
- (a) 2,4-dimethylphenol
- (b) xylenol (mixture of isomers).

NOTE D:

Certain substances which are susceptible to spontaneous polymerization or decomposition are generally placed on the market in a stabilised form. It is in this form that they are listed in the Annex I to this directive.

However, such substances are sometimes placed on the market in a non-stabilised form. In this case, the manufacturer or any person who places such a substance on the market must state on the label the name of the substance followed by the words non-stabilised.

Example:  methacrylic acid (non-stabilised).

NOTE E:

Substances with specific effects on human health (see Chapter 4 of Annex VI) that are classified as carcinogenic, mutagenic and/or toxic for reproduction in categories 1 or 2 are ascribed Note E if they are also classified as very toxic (T+), toxic (T) or harmful (Xn). For these substances, the risk phrases R 20, R 21, R 22, R 23, R 24, R 25, R 26, R 27, R 28, R 39, R 68 (harmful), R 48 and R 65 and all combinations of these risk phrases should be preceded by the word "Also".

Examples:
- R 45-23: "May cause cancer. Also toxic by inhalation"
- R 46-27/28: "May cause heritable genetic damage. Also very toxic in contact with skin and if swallowed".

NOTE F:

This substance may contain a stabiliser. If the stabiliser changes the dangerous properties of the substance, as indicated by the label in Annex I, a label should be provided in accordance with the rules for the labelling of dangerous preparations.

NOTE G:

This substance may be marketed in an explosive form in which case it must be evaluated using the appropriate test methods and a label should be provided reflecting its explosive property.

NOTE H:

The classification and label shown for this substance applies to the dangerous property(ies) indicated by the risk phrase(s) in combination with the category(ies) of danger shown. The requirements of Article 6 of this Directive on manufacturers, distributors and importers of this substance apply to all other aspects of classification and labelling. The final label shall follow the requirements of section 7 of Annex VI of this Directive.

This note applies to certain coal- and oil-derived substances and to certain entries for groups of substances in Annex I.

NOTE J:

The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,1% w/w benzene (Einecs No 200-753-7). This note applies only to certain complex coal- and oil-derived substances in Annex I.

NOTE K:

The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0,1% w/w 1,3-butadiene (Einecs No 203-450-8). If the substance is not classified as a carcinogen or mutagen, at least the S-phrases (2-)9-16 should apply. This note applies only to certain complex oil-derived substances in Annex I.

NOTE L:

The classification as a carcinogen need not apply if it can be shown that the substance contains less than 3% DMSO extract as measured by IP 346. This note applies only to certain complex oil-derived substances in Annex I.

NOTE M:

The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,005% w/w benzo[a]-pyrene (Einecs No 200-028-5). This note applies only to certain complex coal-derived substances in Annex I.

NOTE N:

The classification as a carcinogen need not apply if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen. This note applies only to certain complex oil-derived substances in Annex I.

NOTE P:

The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,1% w/w benzene (Einecs No 200-753-7).

When the substance is classified as a carcinogen, Note E shall also apply.

When the substance is not classified as a carcinogen at least the S-phrases (2-)23-24-62 shall apply.

This note applies only to certain complex oil-derived substances in Annex I.

NOTE Q:

The classification as a carcinogen need not apply if it can be shown that the substance fulfils one of the following conditions:

- a short-term biopersistence test by inhalation has shown that the fibres longer than 0,00002 m have a weighted half life less than 10 days, or

- a short-term biopersistence test by intratracheal instillation has shown that the fibres longer than 0,00002 m have a weighted half life less than 40 days, or

- an appropriate intra-peritoneal test has shown no evidence of excess carcinogenicity, or

- absence of relevant pathogenicity or neoplastic changes in a suitable long term inhalation test.

NOTE R:

The classification as a carcinogen need not apply to fibres with a length weighted geometric mean diameter less two standard geometric errors greater than 0,000006 m.

NOTE S:

This substance may not require a label according to Article 23 (see section 8 of Annex VI).

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Safety phrases

Please also refer to the list of risk phrases.

These phrases appear in the Safety phrase field.  These phrases form part of the labelling for a dangerous substance.

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Risk phrases

Please also refer to the list of safety phrases.

These phrases appear in the Risk phrase field.  These phrases form part of the classification for a dangerous substance.

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Copyright Statement

EINECS Plus 2005:1

Multilingual Databases

EU Chemical Inventories - EINECS/ELINCS/NLPL
List of Dangerous Substances
EU Priority & Prior Consent Lists
EU Indicative Occupational Exposure Limits
Summary of EU Legislation on Dangerous Substances and Preparations (English)
ECICS - European customs inventory of chemical substances
EU Cosmetics Inventory
EU Cosmetics Legislation (English)
EU Waste Catalogue

Product languages (where available): Danish, Dutch, English, French, German, Italian, Portuguese, Spanish, Finnish, Swedish
Interface languages (where available): English, French, German, Spanish

The licensors strongly recommend that you refer to the on-screen guides to help you understand how to use this product.

This database correlates information extracted from EC legislation but has no official status.  Neither the European Commission nor the publishers guarantee its accuracy or accept responsibility for the consequence of its use.  Only the legislative texts are authoritative, as published in the Official Journal of the EC.  For a complete statement of terms of supply, see the EINECS Plus Subscription and Licence Agreement.

Data © European Communities, 2005
Application and software © Croner Publications, 2005

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Guide Revised October 26, 2005

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